Identity
- Trade Name
- AESKULISA® Cenp-B FDA UDI
- Generic Name
- Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. FDA UDI
- Model / Reference
- 3112 FDA UDI
- Description
- AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250289500548 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)
AESKULISA® Cenp-B by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA).
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI 1ac7e6c1-0656-4a78-9146-f3bb58a47c80 34 fields · synced Jun 6, 2026